Draeger Medical, Inc. Carina Sub-Acute Care Ventilator Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Carina Sub-Acute Care Ventilator
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Part No. 5704110, UDI-DI 04048675398516, All Serial No.
Products Sold
Part No. 5704110; UDI-DI 04048675398516; All Serial No.
Draeger Medical, Inc. is recalling Carina Sub-Acute Care Ventilator due to Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Recommended Action
Per FDA guidance
The firm, Drager, sent an "Urgent Medical Device Recall" to customers by mail on 07/12/2023. The medical device recall notification instructs customers on how to utilize the Carina Ventilator until units can be corrected in the field by way of replacement of the blower to remove the presence of PE-PUR foam. Customers may continue to use the device until it has been modified provided that the set minute volume exceeds 3.6 l/min, only adult patients are ventilated, and only a Draeger ventilation hose with leak valve is used. The firm states that a new designed blower cover will be available in the early part of the fourth quarter of 2023 and Draeger will facilitate field service free of charge. Customers are to ensure all users and maintenance staff that utilize the recalled device are made aware of the recall notice. Customers with any questions regarding the operation of the Carina Ventilator are to contact Technical Support between 8:00 AM and 8:00 PM EST at 1-800-437-2437 (press 2, then 2, then 2); customers with any questions about the recall notice are to contact Michael Kelhart from 8:00 AM to 4:30 PM EST at 267-664-1131 or by email at mike.kelhart@draeger.com. The Medical Device Recall Response form is to be returned by fax 215-372-2940 or email: ditelford.quality@draeger.com to Draeger upon completion.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026